A study of using a robot controlling finger movement and botulinum therapy in patients who suffered from stroke

JRCT ID: jRCTs062190016

Registered date:24/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Upper limb spasticity after stroke
• Date of first enrollment: 01/08/2019
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Botulinum therapy is performed in patients with post-stroke upper limb spasticty including finger joints. Immediately after the therapy robot rehabilitation is done for those treated joints. The same rehabilitation is performed at 1 months after the botulinum therapy, when its effect reaches the maximum. The results are evaluated as measuring the active range of motion of the finger joints, and are compared betwen those immediately after and 1month after the botulinum therapy, so that the additive effect of the botulinum therapy and the robot rehabilitation is explored.

Outcome(s)

Primary Outcome

1. Modified Ashworth Scale (MAS) of the finger joints

2. Active ROM (range of motion) of the finger joints

Secondary Outcome

1. Fugel-Myer Assessment of the finger joints
2.Brunnstrom stage of the finger joints
3. Visual Analogue Scale by the patient
4. Sensory function (position, kinesithesia)
5. Any technical problems of the robot

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

aged 20-90
more than 1 year after the onset of stroke
without any recurrence of stroke
cognitive function not decreased (HDSR>23)
No signs of depression
No other active diseases affecting other organs or mental disorders

Exclude criteria

Pregnancy
Serious systemic diseses
Progressive CNS disorders (e.g brain tumors)
contractures or severe spasticity of finger joint (MAS=4)

Related Information

• Primary Sponsor: Fujita Koji
• Secondary Sponsor: Meltin MMI